Federal regulators issued an unusually strong warning Friday to stop eye doctors from using unapproved machines for laser surgery on nearsighted Americans.
The warning is the latest in a blitz of controversy to overtake a popular laser surgery that promises better vision without glasses to many of the 60-million Americans who are nearsighted.
The FDA has approved two lasers since last fall, made by Summit Technology and Visx, to help people see more clearly at a distance.
But some doctors are importing cheaper used lasers from Europe, where they have been sold for several years, or building their own, meaning some patients are undergoing surgery on machines not approved by the FDA as safe.
That's illegal, the FDA warned at a meeting of eye specialists Friday. Doctors either must use FDA-approved lasers or, if they think their own lasers are superior, get government permission to study them while informing patients that the devices are experimental.
"Be on the alert: We will take action against illegal product in the marketplace," said Dr. Susan Alpert, FDA's device evaluation chief.
The agency could seize an unapproved machine or get a court injunction to stop its use.
The FDA does not know how many unapproved lasers are being used. Alpert advised patients to ask their doctors before surgery about the machine they use and their success rate. She also advised that patients demand FDA-approved patient leaflets and ask to speak with previous patients.
"This _ let us be clear _ is irreversible surgery," she said. "Wait until you're sure."
Outraged doctors said that they are offering their patients better care than the FDA-approved equipment can provide and that the FDA has no business interfering in their practice of medicine.
"Why did I get involved in non-regulated lasers?" asked Dr. Ralph Berkely of Houston, who built his own laser. "My moral and ethical responsibility to do what I believe is in the best interest of my patients."
If the FDA would speed up its review of new lasers to keep up with Europe, doctors wouldn't be forced to use "untested techniques," said Dr. Stephen Trokel of the American Society for Cataract and Refractive Surgery.
In photorefractive keratectomy, or PRK, a laser burns off bits of the corneal surface to flatten it and improve mild or moderate nearsightedness.
Some 30,000 eyes have been treated so far, but PRK already is controversial:
Last spring, the FDA and Federal Trade Commission warned thousands of doctors against falsely advertising PRK. Ads saying consumers could "throw away your glasses" glossed over the risks and seemingly promised perfection, the warning said. While PRK usually works well, it sometimes results in patients needing reading glasses or causes glare, hazy vision and other problems.
In Idaho, ophthalmologists, who have medical degrees, have sued optometrists, who don't, to stop them from offering PRK. The optometrists say PRK is so computerized that no special surgical skill is needed.
The newest fight comes because the FDA-approved lasers don't perform higher-powered surgery to correct severe nearsightedness, which European models or home-built ones can do.